Product Registration and Maintenance

• Analyze registration complexities and provide regulatory guidance to align with company’s business goals.
• Manage regulatory plans across Singapore and APAC for new and existing products, variations, modifications, renewals and compliance.
• Prepare technical dossiers for submission to regulatory authorities.
• Draft well-written responses to regulatory authorities’ inquiries
• Follow up on product license renewals.
• Support post-market regulatory activities (e.g. adverse reporting, recalls)

Quality Management System Compliance

• Maintain a thorough understanding of relevant regulatory policies and ensure compliance.
• Prepare and uphold local SOPs and policies related to Regulatory Affairs in alignment with company standards and Regulatory Authority requirements.
• Provide regulatory input and support for company policies and activities to ensure compliance to relevant regulatory policies (e.g. marketing plans & materials, product artwork, change controls)
• Maintain organized regulatory files and product licenses.

Regulatory Intelligence

• Gather and analyze regulatory intelligence, integrating trends into decision-making processes.
• Stay updated on device regulations, changes, guidance, and standards relevant to product submissions, analyzing and providing updates as necessary.

Others
Perform additional ad-hoc duties as assigned.

Requirements

• Degree in Life Sciences, Engineering, Pharmacy, Pharmaceutical Science or a related field.
• Minimum of 5 years’ experience in medical device industry.
• Possess a thorough understanding of Health Sciences Authority and overseas (e.g. APAC, EU Medical Device Directive/Regulation, US FDA) medical device regulations.
• Prior working experience in an ISO 13485:2016 environment is a plus.
• Understand business needs and the implications of regulatory issues.
• Excellent communication skills, with proficiency in written and spoken English.
• Proficiency in Microsoft Office.
• Independent, meticulous, detail-oriented, and proactive.
• Strong multitasking ability and a proactive approach.
• Positive attitude with a passion for learning and development.
• Ability to adapt in a fast-paced environment.